Degenerative joint diseases, commonly known as orthroses, are most frequently found in bradytrophic tissue (tendon, cartilage) which is known to show little or no blood flow and, because of its slow metabolism, is incapable of responding to external noxious influences either with inflammatory and or with regenerative processes. As brought out in Koepff et al U.S. Pat. No. 4,804,745, clinical investigations have now led to the discovery that peptides soluble in cold water, and specifically those from a group of hydrolyzed collagens, are suitable for the treatment of orthoses. Particularly suitable is an enzymatically hydrolyzed collagen having an average molecular weight of from 10,000 to 80,000 daltons. Such enzymatically hydrolyzed collagen is almost flavorless or neutral in flavor, is soluble in cold water, and, unlike denatured collagen (gelatin) is incapable of binding significant amounts of water.
Collagen is a fiber protein forming the main constituent of the supporting tissue and connective tissue in animals (including humans) and, more particularly, is found in the skin, tendons and bones. Therefore, hydrolyzed collagen, and specifically enzymatically hydrolyzed collagen, may be produced from animal skin, animal bones, and other sufficiently purified connective tissue. Such enzymatically hydrolyzed collagens have previously been used in the pharmaceutical industry as tabletting aids, encasing agents and fillers. U.S. Pat. No. 4,804,745 describes that clinical investigations and double blind studies have now established that these enzymatically hydrolyzed collagens, taken in an amount of from 5 to 12 g per day, have alleviating effects on orthoses and also produce an analgesic effect which tends to reduce the need for administering other analgesics.
Recent studies have also shown the beneficial effects of glucosamine sulfate and its relationship with the symptoms of osteoarthritis, the most common form of arthritis. Glucosamine sulfate, which is naturally found in high concentrations in joint structures, is a stable, tasteless and water-soluble nutrient. It is readily absorbed from the intestines, stays in the blood for several hours, and very little is excreted. Glucosamine sulfate, taken as a dietary supplement, has been shown to exert a protective effect against joint destruction and is selectively used by joint tissues, exerting a dramatic positive effect in reducing arthritic symptoms and promoting healthy joint function. In particular, glucosamine stimulates the body's manufacture of collagen, the protein portion of the fibrous substance that holds joints together. Collagen is the main component of the shock-absorbing cushion called articular cartilage, and glucosamine is therefore a necessary nutrient in the production of cartilage and synovial fluid. However, the body's production of glucosamine decreases as a person ages, thereby inhibiting the new growth of cartilage destroyed through wear and tear.
The composition of this invention is a dietary supplement containing both glucosamine sulfate and protein derived from the enzymatic hydrolysis of collagen in combination with certain antioxidants, anti-inflammatory agents, thermonutrients for increasing absorption and utilization of other nutrients, and an herbal blend composed of ingredients that coact with other components to promote healthy joint function. More specifically, the dietary supplement takes the form of an essentially dry mixture of 78% to 90% protein derived from the enzymatic hydrolysis of collagen, 2% to 6% glucosamine sulfate, 2% to 5% ginkgo biloba (Salsburia adiantifolia) , 0.8% to 1.5% borage oil powder (Borago officinalis), 0.3% to 0.7% turmeric (Curcuma longa), 0.01% to 0.03% Boswellia serrata, 0.5% to 0.7% ashwagandha (Withania sominfera), 0.04% to 0.08% Piper nigrum extract, and 5% to 10% herbal blend. In a preferred embodiment, the herbal blend includes cat's claw powder (Uncaria tomentosa), sarsaparilla root (Smilax ornata), licorice root (Glycyrrhiza glabra), kelp (Ascophyllum nodosum), burdock root powder (Arctium lappa), alfalfa powder (Medicajo sativa), barley grass (B. Hordeum vulgare L.), echinacea root (Echinacea purpurea), yucca extract (Yucca schidigera), bilberry extract (Vaccinium myrtillus), devil's claw powder Harpagophytum procumens, capsicum powder (Capsicum annum linne var. Longum sendt capsuccum) celery seed powder, and aloe vera extract.
Once the essentially dry mixture has been blended, the. composition can be delivered enterally as a beverage. The beverage is prepared by dissolving the proper amount of the essentially dry mixture in water, juice, milk or any other drinkable liquid. The recommended serving size is 7 to 10 g of the essentially dry mixture, optimally 8.5 g of that mixture, in a selected beverage. The recommended serving should be consumed once each day.